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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion.
Awards & highlights
Study Summary
This trial investigates if beetroot juice can help stroke survivors walk better by improving oxygen capacity.
Who is the study for?
This trial is for adults aged 18-89 who had a stroke more than six months ago and now have difficulty moving one side of their body. They must be able to understand English, follow simple instructions, and walk at least a little bit with or without help like braces or canes.Check my eligibility
What is being tested?
The study is testing if drinking beetroot juice helps improve the amount of oxygen people use when walking after having a stroke. Participants will try both the beetroot juice and a placebo supplement that has no active ingredients to compare effects.See study design
What are the potential side effects?
Beetroot juice may cause low blood pressure, stomach upset, colored stool or urine due to its natural pigments. The placebo should not have any active effects but could cause similar symptoms if participants expect them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measures assessed prior to and following 2-3 hours after beetroot juice or placebo ingestion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in gait efficiency during steady state walking
Changes in plasma levels of Nitrate and Nitrite
Secondary outcome measures
Changes in peak Treadmill Speed
Changes in peak heart rate during the graded treadmill test
Changes in peak oxygen consumption during maximum gait speed
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Beetroot Juice SupplementExperimental Treatment1 Intervention
140 mL of beetroot juice supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
Group II: Placebo SupplementPlacebo Group1 Intervention
140 mL of placebo supplement will be ingested orally (Beet-It Nitrate 400, James White Co).
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,957 Total Patients Enrolled
13 Trials studying Stroke
4,037 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have problems with the part of your brain called the cerebellum.You have any other problems with your brain or bones that make it hard for you to walk.You are a smoker.You have a disease affecting your metabolism, breathing, or heart that is not being managed well.You are between 18 and 89 years old.You have had weakness on one side of your body for a long time after a stroke.You can walk at least 0.3 meters per second, with or without using a cane or brace below your knee.You can understand and follow simple instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Beetroot Juice Supplement
- Group 2: Placebo Supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To which population is eligibility for this research study open?
"To be eligible, individuals should have suffered from a stroke and must fall between 18-89 years of age. The recruitment protocol for this project is to enlist 25 people in total."
Answered by AI
Is the age requirement for this medical experiment restricted to those under 35 years old?
"This trial is open for applicants between the ages of 18 to 89. There are 34 trials available specifically for minors, and 991 clinical studies targeting elderly patients in this age range."
Answered by AI
Does this research still have spots available for participants?
"The clinicaltrials.gov database has not listed this medical experiment as actively seeking patient volunteers, despite its initial posting on February 1st 2023 and last edit occuring on January 30th 2023. Nevertheless, there are a plethora of other studies that require enrollment at the present moment."
Answered by AI
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